Duns Number:830016148
Device Description: 3M™ ESPE™ Adper™ Scotchbond™ Multi-Purpose Plus Activator, 7546
Catalog Number
7546
Brand Name
Adper™ Scotchbond™
Version/Model Number
7546
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 03, 2023
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
21cbb2b5-f90d-4678-92a1-1a5290458efa
Public Version Date
November 01, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50605861035656
Quantity per Package
10
Contains DI Package
30605861035652
Package Discontinue Date
October 03, 2023
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |